Active, not recruitingNCT02384733Updated Jul 8, 2021

Hypofractionated Loco-regional Adjuvant Radiation Therapy of Breast Cancer Combined With a Simultaneous Integrated Boost

An interventional study of Loco-regional RT in Lymphedema and Fibrosis, sponsored by Danish Breast Cancer Cooperative Group. Active, not recruiting at 1 site in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-08.

Sponsored by Danish Breast Cancer Cooperative Group · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 2,963
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study summary

The purpose of the study is to investigate the difference in late radiation morbidity between hypofractionated and normofractionated loco-regional breast irradiation irrespective of mastectomy or lumpectomy. In patients who a candidates for a boost, the boost will be provided as a simultaneous integrated boost.

Read the detailed description

The randomization is between 50 Gy / 25 fractions and 40 Gy/15 fractions, 5 fractions weekly. In patients treated with boost 2 dose levels are accepted: 16 Gy/8 fractions and 10 Gy/5 fractions. These boost treatments will be provided as simultaneous integrated boost, where the overall treatment time in general is shortened 5 days. Thus the dose levels for boost patients are:

63 Gy / 51.52 Gy / 28 fractions, 57 Gy / 50 Gy / 25 fractions, 52.2 Gy / 42.3 Gy / 18 fractions, and 45.75 Gy / 40 Gy / 15 fractions.

The primary endpoint is arm lymphedema 3 years after radiation therapy, but other late radiation morbidities will also be evaluated along with recurrence and sites of recurrence. Follow up of morbidity will continue for 10 years.

The hypothesis is that women operated for early breast cancer with indication for loco-regional radiation therapy can be offered moderately hypofractionated therapy without developing more late radiation induced morbidity compared to normofractionated radiation therapy.

Conditions studied

Lymphedema
Fibrosis

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Keywords

Radiation induced morbidity, recurrence

In context

Lymphedema

529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.

This study's enrollment of 2,963 is above the median of 50 across 369 interventional studies indexed under Lymphedema.

Browse Lymphedema studies →

Lead sponsor

Danish Breast Cancer Cooperative Group is the lead sponsor of 12 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Operated for early node-positive breast cancer with indication for loco-regional breast radiotherapy

Exclusion criteria

Exclusion Criteria:

Previous radiotherapy to chest wall, pregnant/lactating, comorbidity which may hinder 10 years follow up

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 2,963 participants (actual)

Study arms

Experimental
Hypofractionated loco-regional RT
40 Gy / 15 fractions, 2.67 Gy per fraction, 5 fractions weekly
Radiation: Loco-regional RT
Active comparator
Normofractionated loco-regional RT
50 Gy / 25 fractions, 2.00 Gy per fraction, 5 fractions weekly
Radiation: Loco-regional RT

Interventions

RadiationLoco-regional RT

What researchers measure

Primary outcomes

Development of ipsilateral arm lymphedema
\>=10% increased arm circumference compared to the other arm defines edema
Time frame: 3 years

Secondary outcomes

Fibrosis grade 2-3
Breast or chest wall induration
Time frame: 3 years
Arm range of motion
Impaired shoulder movement is present when \>20 degrees difference between arms at flexion and/or abduction
Time frame: 3 years
Development of dyspigmentation
Grade 2 or worse dyspigmentation compared to baseline
Time frame: 3 years
Recurrence
Any recurrence location and time to event
Time frame: 10 years
Development of pain in the irradiated area
Pain in the irradiated area measured on visual analog scale compared to baseline
Time frame: 3 years
Change in sensibility
Change in sensibility in the irradiated area compared to baseline measured as yes/no
Time frame: 3 years
Development of edema on breast / chest wall
Grade 2 or worse edema
Time frame: 3 years
Development of telangiectasia in irradiated area
Grade 2 or worse telangiectasia
Time frame: 3 years

Study locations

1 site

Aarhus University Hospital
Aarhus, Denmark
320 other open studies at this site →

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2015 to primary completion in Jul 2021, 76 months.

Of 175 non-industry interventional studies with no phase under Lymphedema, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 68. This study's 76 months is above that.

Counting every sponsor, half of 197 studies reached it within 25 months; a quarter within 9 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 19, 2015
First posted: Mar 10, 2015
StartActual: Mar 2015
Primary completionActual: Jul 1, 2021
CompletionEst.: Jul 1, 2032
Last update: Jul 8, 2021

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jul 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02384733
Lead sponsor: Danish Breast Cancer Cooperative Group
Collaborators: Danish Cancer Society
Responsible party: Birgitte Offersen (MD, professor, ph.d., Danish Breast Cancer Cooperative Group) — Principal investigator
First posted: Mar 10, 2015
Start date: Mar 2015
Primary completion: Jul 1, 2021
Completion: Jul 1, 2032 (estimated)
Last update: Jul 8, 2021

Study contacts

Lars Stenbygaard, MD

study chair · Aalborg University Hospital

Troels Bechmann, MD,PhD

study chair · Vejle Hospital

Mette Nielsen, MD

study chair · Odense University Hospital

Birgitte Offersen, MD

principal investigator · Aarhus University Hospital

Hanne Nielsen, MD

study chair · Aarhus University Hospital

Claus Kamby, MD

study chair · Rigshospitalet, Denmark

Sami Al-Rawi, MD

study chair · Naestved Hospital

Mechthild Krause, MD

study chair · Technische Universität Dresden Klinik und Poliklinik für Strahlentherapie und Radioonkologie

Andreas Schreiber, MD

study chair · Praxis für Strahlentherapie, Dresden

Ingvil Mjaaland, MD

study chair · Stavanger Hospital

Tanja Marinko, MD

study chair · Institute of Oncology Ljubljana

Carine Kirkove, MD

study chair · Radiotherapy Department Université Catholique de Louvain, Cliniques Universitaires St-Luc, Brussels

Egil Blix, MD

study chair · University Hospital of North Norway, Tromsoe

Unn-Miriam Kasti

study chair · Kristiansand Hospital, Norway

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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